Overview

This study is being done to find out how often endometrial cancer recurs after the standard treatment as well as how often the standard treatment results in a lymphedema.

Eligibility

Screening Inclusion Criteria:

• ECOG performance status 0-1 or KPS ≥ 70%
• Age ≥ 18 years
• Endometrioid adenocarcinoma histologic diagnosis on endometrial biopsy or dilatation and curettage
• No evidence of extrauterine disease, or suspicious pelvic lymph nodes, or distant metastases, or cervical invasion on pre-operative conventional imaging studies (Pelvic +/- Abdomen CT or MRI or sonogram, or body PET scan) and physical examination (uterine confined by exam and imaging )
• Suitable candidate for surgery
• Planned surgical treatment including hysterectomy in combination with SLN biopsy and a bilateral salpingo-oophorectomy
• No history of second primary cancer (invasive or in situ) within the past 5 years, not including non-melanoma skin cancer
• Approved and signed informed consent
• No history of neoadjuvant chemotherapy or radiotherapy for endometrial cancer
• No history of prior pelvic or abdominal radiotherapy

Screening Exclusion Criteria:

• Extrauterine disease, or gross lymph node involvement, or cervical invasion suspected on pre-operative imaging studies and physical examination (disease not uterine confined clinical stage > I)
• Contraindication for SLN mapping
• The planned treatment is not surgery, or the surgical treatment does not include hysterectomy in combination with SLN biopsy and a bilateral salpingo-oophorectomy

Eligibility Inclusion Criteria

        Patients will be classified in the study cohort (part 2; n=182) according to surgical
        treatment received, final post hysterectomy and staging pathologic report, and planned
        adjuvant treatment. The inclusion criteria are specified below.
        Study Cohort (n=182)
        A patient will be enrolled in the study cohort if all the following criteria are met:
          -  At surgery, the patient must undergo:
               -  Hysterectomy
               -  Bilateral salpingo-oophorectomy, unless already previously performed
               -  Bilateral pelvic SLN mapping (bilateral sentinel nodes are negative for
                  malignancy)
          -  On the final pathologic report, the patient must have a diagnosis of:
               -  Stage I intermediate-risk endometrial endometrioid cancer (Grade 1 or Grade 2
                  with ≥ 50% myometrial invasion or Grade 3 with <50% myometrial invasion,
                  including non-invasive disease)
               -  Negative pelvic peritoneal cytology
          -  Adjuvant treatment as recommended by the multidisciplinary team must be as follows:
               -  No adjuvant treatment, or
               -  Intravaginal radiation only
        Eligibility Exclusion Criteria
          -  There is intra-operative detection of extra-uterine disease or grossly involved lymph
             nodes
          -  Presence of any positive pelvic nodes including micrometastasis and isolated tumor
             cells (ITC)
          -  Hysterectomy is not performed
          -  Bilateral salpingo-oophorectomy is not performed, unless already previously performed
          -  Failed unilateral or bilateral SLN mapping
          -  Patient undergoes a complete unilateral or bilateral pelvic lymphadenectomy
          -  Patient undergoes a radical type C hysterectomy
          -  Stage IA endometrioid cancer Grade1 or 2 and myometrial invasion <50%
          -  Stage IB Grade 3 endometrioid cancer
          -  Non-endometrioid histology: Serous, clear cell, carcinosarcoma, undifferentiated, or
             de-differentiated histology noted on final hysterectomy pathology
          -  Empty unilateral or bilateral sentinel lymph nodal packet(s)
          -  Positive peritoneal cytology